Lactobacillus Plantarum P8 for Its Brain Health Promotion Potential

Healthy Volunteers Clinical Trial

— P8  

Official title:

Lactobacillus Plantarum P8 for Its Brain Health Promotion Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268447
• Other study ID #: USM/JEPeM/16050195
• Status: Completed
• Phase: N/A
• Start date: August 5, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: July 2018
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health properties, primarily alleviation of stress, among adults in Malaysia aged from 18 to 60 years.

Description:

The emerging concept of gut-brain-axis has been implying that gut health plays a pivotal role in maintaining brain health4. Probiotics have entered the picture in promoting gut health for better brain health. Probiotic can be defined as "live microorganisms that grant health effects to the host if consumed in sufficient amounts". Lactobacilli, as one of the largest genera for probiotic microorganisms have been researched to alleviate stress, anxiety and/or depression disorders.

L. plantarum P8 was isolated from traditionally fermented sour milk samples collected from herdsmen in Wulatezhongqi grassland, Bayannaoer, Inner Mongolia, China. L. plantarum P8 was selected as it was the best among 347 other Lactobacillus strains with excellent tolerance to gastric acid, intestinal fluid and bile salt of the digestive system. P8 is incorporated and sold in the market of China, Taiwan and Singapore in a variety of products, ranging from dairy (yoghurt and fermented milk), health supplements to pet foods. P8 is patented in China and also awarded by the Chinese government as a functional probiotic. Two human clinical trials have shown that the administration of P8 at a concentration of 10 log CFU/day for 4-weeks, improved gastrointestinal health of adults subjects via increasing the population of beneficial gut microbiota accompanied by decreasing gut opportunistic pathogens, increasing fecal levels of secretory immunoglobulin-A and short chain fatty acids.

Thus, with evidence from other studies supporting the stress-alleviation effects of lactobacilli and the current gut modulation properties of P8, we believe that L. plantarum P8 could exert stress alleviation potentials as well.

P8 has confirmed its safety for consumption, and for this intervention, it will be produced under ISO9001 and HALAL in China. HALAL certification is provided by ARA HALAL Development Services Center Inc. (ARA), which is recognized by JAKIM, Malaysia, an organization that oversees the implementation of Halal requirement in Malaysia.

A total number of 176 healthy adults from age 18 -60 years old will be recruited for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male or female subjects

• 18-60 years old

• No severe illness

• BMI within a healthy range

• Score between 13 -20 (moderate stress level) on Cohen's Perceived Stress Scale (PSS)

• Willing to commit throughout the experiment

Exclusion Criteria:

• Type-1 diabetes (one of the main metabolite of Lactobacillus is acetic acid. Acetic acid has been reported to affect lipid metabolism in the liver and fat digestion in the pancreas in animal studies, and has been applied in obesity studies)

• Long term medication due to certain severe illness (certain medications may interfere with the survivability of Lactobacillus in the gut, for example the interactions between probiotics and warfarin

• HIV/AIDS (there has been no substantial data on the detrimental effects of probiotics on AIDS patients. However, AIDS patient may be immune-compromised in the sense of "leaky gut" that may lead to bacterial translocation, including translocation of Lactobacillus outside the gut environment, into the blood stream)

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (there has been no substantial data on the detrimental effects of probiotics on G6PD deficiency people. However, certain strains of probiotics have been reported to benefit RBC irregularity disorders such as spur cells formation. One of the main mechanisms, involve the alteration of RBC membrane. Although this is a benefit, we are unsure of the effects on G6PD deficiency people, with weaker RBC).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Lactobacillus plantarum P8
This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.
• Placebo
This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.

Locations

Country	Name	City	State
Malaysia	School of Industrial Technology	Universiti Sains Malaysia	Penang

Sponsors (2)

Lead Sponsor	Collaborator
University of Science Malaysia	Beijing Scitop Bio-Tech Shareholding Co.Ltd.

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

Kwok LY, Guo Z, Zhang J, Wang L, Qiao J, Hou Q, Zheng Y, Zhang H. The impact of oral consumption of Lactobacillus plantarum P-8 on faecal bacteria revealed by pyrosequencing. Benef Microbes. 2015;6(4):405-13. doi: 10.3920/BM2014.0063. Epub 2015 Feb 12. — View Citation

Wang, L.F., Zhang JC, Zhuang G, Kwok L, Chen M, Zhang WY, Qiang LV, Huang WQ, ,Zhang HP. (2014). The Impact of Oral Consumption of the Probiotic Lactobacillus plantarum P8 on the Faecal Microbiota, SIgA, SCFAs and TBAs of Subjects of Different Age. Nutrition 8: 776-83

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress Scale (PSS) Scores	Stress Questionnaires for the determination of stress (low, moderate, high)	12 weeks
Secondary	Fecal microbiota profiling	Deoxyribonucleic acid (DNA) sequencing of fecal samples to compare DNA sequences of the different microbiota between adult participants taking P8 vs. placebo	12 weeks